Mogen

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Pictured: Mogen Clamp
Pictured: Barzel Tool

The Mogen clamp was invented in 1954[1] by a Rabbi Harry Bronstein.[2] It is actually one of many successors to the much older, traditional barzel device.[3] The Mogen clamp's name derives from the Hebrew word "magain," or shield, and it was invented in an effort to standardize circumcision equipment then in use by both doctors and mohels without medical training who perform the procedure in private homes and other locations.[4] The device is designed to "shield" the glans, as the name implies, while the mohel slices off the foreskin. A user must first rip the foreskin from the glans, then pull it through the clamp and slices it off with a single motion.[5] Some orthodox Jews only recognize circumcisions performed with devices based on the traditional design,[6] and for this reason it is preferred by traditional mohels.[7]

Contents

Injury reports

The Mogen clamp has a critical design flaw: It does not allow doctors or mohels to see what they are cutting.[8] As far back as August 2000, the U.S. Food and Drug Administration issued a public health notice about the Mogen and Gomco clamps[9] after receiving approximately 20 injury reports a year since 1996,[10] including lacerations, hemorrhaging, penile amputation and urethral damage.[11] Instead of recalling the devices, the FDA advised users to make sure they were using the clamps according to manufacturer's specifications.[12] In the 11 years following the FDA warnings, the agency had received 21 reports related to Mogen clamps, all but one of which involved injuries.[13] Mogen continued to publish in its instructional brochure that "no injury to the glans is possible, even after other glans amputations were reported.[14] Full or partial glans amputations have been reported for the Mogen clamp, even among experienced conductors of circumcision.[15][16]

Mogen goes out of business

Mogen went out of business in July of 2010[17] after losing a 10.8 million dollar law suit,[18] after a mohel[19] severed the end of a baby's glans[20] using one of their clamps. Mogen claimed that injury was impossible with its use.[21][14] The injury behind a prior lawsuit in Fulton County Superior Court had already put Mogen on notice about the danger of the device,[22] and they were already in default on a $7.5-million judgment in Massachusetts.[23]

In a different case, at South Fulton Medical Center, another law suit was won in 2009.[24] In that case, a child lost a third of his glans, and the plaintifs were awarded 2.3 million dollars.[25]

Other law suits involving Mogen

Mogen clamps were made by other manufacturers, including Miltex, which stopped distributing the devices in 1994.[26] Even then, Miltex's then-president Saul Kleinkramer defended the device, placing the blame on "possible mishandling" instead of the design of the device.[27] Despite having stopped distributing the devices in 1994, some Miltex manufactured Mogen clamps are still in use[28], and Miltex, along with their parent company, Integra Life Sciences Holding Corp., were recently involved (July 2011) in a $4.6-million settlement.[29] Miltex reached a confidential settlement with a North Hollywood couple for another Mogen-related circumcision botch in 2000.[30] In its response to the lawsuit, Integra maintained that the Mogen clamp was safe, carried adequate warnings and users should be held liable for any harm caused.[31]

Usage in Africa

Despite going out of business in America, and despite its notoriety for glans amputations, Mogen clamps are being used in a pilot project to have male children circumcised at birth under the pretext of HIV prevention.[32]

References

  1.   Use of the Mogen clamp for neonatal circumcision. Retrieved 8 April 2011.
    Quote: The Mogen clamp was invented in 1954 by Rabbi Harry Bronstein, a Brooklyn mohel.
  2.   Hennessy-Fiske, Molly (26 September 2011)."Injuries linked to circumcision clamps". Retrieved 25 September 2011.
    Quote: It was invented in 1954 by Rabbi Harry Bronstein...
  3.   (8 April 2011). Methods of circumcision, circumstitions.com [deprecated REFweb parameter used: use <website> instead]. Retrieved 8 April 2011.
    Quote: The barzel (Hebrew for iron) also known as a mogen (Hebrew for shield) is a slotted shield ...
  4.   Hennessy-Fiske, Molly (26 September 2011)."Injuries linked to circumcision clamps". Retrieved 25 September 2011.
    Quote: The Mogen clamp's name derives from the Hebrew word "magain," or shield...
  5.   Hennessy-Fiske, Molly (26 September 2011)."Injuries linked to circumcision clamps". Retrieved 25 September 2011.
    Quote: A user first loosens the foreskin, then pulls it through the clamp and clips it off with a single cut.
  6.   Hennessy-Fiske, Molly (26 September 2011)."Injuries linked to circumcision clamps". Retrieved 25 September 2011.
    Quote: ...some orthodox Jews recognize only circumcisions performed with devices based on the traditional design...
  7.   Hennessy-Fiske, Molly (26 September 2011)."Injuries linked to circumcision clamps". Retrieved 25 September 2011.
    Quote: ...the clamp is popular with mohels...
  8.   Hennessy-Fiske, Molly (26 September 2011)."Injuries linked to circumcision clamps". Retrieved 25 September 2011.
    Quote: ...the Mogen clamp, unlike others, has a critical design flaw: It does not allow doctors or mohels to see what they are cutting.
  9.   Hennessy-Fiske, Molly (26 September 2011)."Injuries linked to circumcision clamps". Retrieved 25 September 2011.
    Quote: As far back as August 2000, the U.S. Food and Drug Administration issued a public health notice about the Mogen...
  10.   Hennessy-Fiske, Molly (26 September 2011)."Injuries linked to circumcision clamps". Retrieved 25 September 2011.
    Quote: ...after receiving approximately 20 injury reports a year since 1996...
  11.   Hennessy-Fiske, Molly (26 September 2011)."Injuries linked to circumcision clamps". Retrieved 25 September 2011.
    Quote: ...including lacerations, hemorrhaging, penile amputation and urethral damage...
  12.   Hennessy-Fiske, Molly (26 September 2011)."Injuries linked to circumcision clamps". Retrieved 25 September 2011.
    Quote: Instead of recalling the devices, the FDA advised users...
  13.   Hennessy-Fiske, Molly (26 September 2011)."Injuries linked to circumcision clamps". Retrieved 25 September 2011.
    Quote: In the 11 years between the FDA warnings and the Hall settlement, the agency has received 21 reports related to Mogen...
  14. a b   Hayes Tucker, Katheryn (29 July 2010)."Atlanta Lawyer Takes on Botched Circumcision Claims Nationwide". Retrieved 8 April 2011.
    Quote: She noted an instructional brochure accompanying the Mogel clamp stating that "no injury to glans is possible," even though other amputations had been reported.
  15.   Taeusch, H William; with Alma M Martinez, J Colin Partridge, Susan Sniderman, Jennifer Armstrong-Wells, Elena Fuentes-Afflick [deprecated REFjournal parameter used: <coauthors> - please use <last2>, etc.]. Pain During Mogen or PlastiBell Circumcision. Journal of Perinatology. error; 22(3): 214-218. Retrieved 8 April 2011.
    Quote: ...approximately 10% of the glans of a newborn was amputated (it was reattached surgically) during a Mogen circumcision carried out by two of our most experienced physicians.
  16.   Tagami, Ty (19 July 2010)."Atlanta lawyer wins $11 million lawsuit for family in botched circumcision". Retrieved 8 April 2011.
    Quote: In this case, a New York mohel, or Jewish ritual circumcisor, performed the operation in the baby's home...
  17.   Tagami, Ty (19 July 2010)."Atlanta lawyer wins $11 million lawsuit for family in botched circumcision". Retrieved 8 April 2011.
    Quote: The company is going out of business, according to a woman who answered the phone at its Brooklyn headquarters Monday.
  18.   Tagami, Ty (19 July 2010)."Atlanta lawyer wins $11 million lawsuit for family in botched circumcision". Retrieved 8 April 2011.
    Quote: ...after an infant lost a portion of his penis during an operation with the Mogen clamp, a judge awarded $10.8 million in damages against the company.
  19.   Tagami, Ty (19 July 2010)."Atlanta lawyer wins $11 million lawsuit for family in botched circumcision". Retrieved 8 April 2011.
    Quote: In this case, a New York mohel, or Jewish ritual circumcisor, performed the operation in the baby's home...
  20.   Tagami, Ty (19 July 2010)."Atlanta lawyer wins $11 million lawsuit for family in botched circumcision". Retrieved 8 April 2011.
    Quote: The baby in the current case, identified in court documents only as L.G., lost the entire glans, or head, of his penis ...
  21.   Tagami, Ty (19 July 2010)."Atlanta lawyer wins $11 million lawsuit for family in botched circumcision". Retrieved 8 April 2011.
    Quote: The maker of an instrument used in circumcisions claimed that injury was impossible with its use...
  22.   Tagami, Ty (19 July 2010)."Atlanta lawyer wins $11 million lawsuit for family in botched circumcision". Retrieved 8 April 2011.
    Quote: Attorney David Llewellyn won a similar case in Atlanta last year and the injury behind that prior lawsuit in Fulton County Superior Court put the New York clamp manufacturer on notice about the danger of the device...
  23.   Hennessy-Fiske, Molly (26 September 2011)."Injuries linked to circumcision clamps". Retrieved 25 September 2011.
    Quote: Mogen Circumcision Instruments of New York, already was in default on a $7.5-million judgment in Massachusetts.
  24.   Tagami, Ty (19 July 2010)."Atlanta lawyer wins $11 million lawsuit for family in botched circumcision". Retrieved 8 April 2011.
    Quote: Llewellyn won another circumcision case in 2009 over an operation at South Fulton Medical Center.
  25.   Tagami, Ty (19 July 2010)."Atlanta lawyer wins $11 million lawsuit for family in botched circumcision". Retrieved 8 April 2011.
    Quote: The jury found that both the pediatrician and the physician who performed the circumcision were negligent, and awarded $2.3 million to the plaintiffs.
  26.   Hennessy-Fiske, Molly (26 September 2011)."Injuries linked to circumcision clamps". Retrieved 25 September 2011.
    Quote: Miltex, one of several Mogen clamp manufacturers, stopped distributing the devices in 1994.
  27.   Hennessy-Fiske, Molly (26 September 2011)."Injuries linked to circumcision clamps". Retrieved 25 September 2011.
    Quote: ...though no obvious defect has been found with the clamp's design or manufacturing we have concerns over the possible mishandling of the instrument by practitioners...
  28.   Hennessy-Fiske, Molly (26 September 2011)."Injuries linked to circumcision clamps". Retrieved 25 September 2011.
    Quote: But some of its devices are still in use.
  29.   Hennessy-Fiske, Molly (26 September 2011)."Injuries linked to circumcision clamps". Retrieved 25 September 2011.
    Quote: Miltex Inc. and its parent company, Integra Life Sciences Holding Corp., agreed this summer to a $4.6-million settlement.
  30.   Hennessy-Fiske, Molly (26 September 2011)."Injuries linked to circumcision clamps". Retrieved 25 September 2011.
    Quote: In 2000, Miltex reached a confidential settlement with a North Hollywood couple...
  31.   Hennessy-Fiske, Molly (26 September 2011)."Injuries linked to circumcision clamps". Retrieved 25 September 2011.
    Quote: Integra argued that the Mogen clamp was safe, carried adequate warnings and that those who used it should be held responsible for any harm caused.
  32.   (September 2010)."Infants targeted in Kenya circumcision project". Retrieved 8 April 2011.
    Quote: He explained that the nurses will use special gadgets known as a Mogen clamp to perform the circumcision at birth.